Clinical Research Clinical Research 367 Questions Ask question Search Order By: ActiveClear Filter 0 Votes 1 Ans Could you give us your input regarding the parameters that should be taken into account so that a more realistic and accurate budget can be planned? 1.57K viewsClinical Research 0 Votes 1 Ans What suggestions do you have for renegotiating a portion of the budget? 1.33K viewsClinical Research 0 Votes 1 Ans We have had difficulty negotiating to be reimbursed for subject screening activity. On some studies, we can spend multiple hours each week searching through patient charts that don’t end up enrolling in the study. Do you have any recommendations as to how to get this time reimbursed? 1.62K viewsClinical Research 0 Votes 1 Ans How do you handle sponsors that will not agree to pay for overhead on patient travel reimbursement? 1.62K viewsClinical Research 0 Votes 1 Ans How does the funding source of the clinical trial study impact the coverage analysis (federally funded vs. industry funded)? 1.55K viewsClinical Research 0 Votes 1 Ans Does any of the NCD 310.1 apply to device trials or is that completely separate? 1.57K viewsClinical Research 0 Votes 1 Ans Are you seeing more sponsors providing coverage analysis, similar to what SWOG has initiated? 1.34K viewsClinical Research 0 Votes 1 Ans The ICH E3 Guideline provides limited guidance on the synopsis. In the ICH M4E Guideline, additional guidance on the synopsis of a CSR is given including its use as a stand-alone document and its length. While E3 asks for a usual maximum length of 3 pages, M4E extends this page limit for more complex and important studies, e.g., to 10 pages. How should both Guidelines be read together? 1.52K viewsClinical Research 0 Votes 1 Ans The CSR appendices described in the ICH E3 include material now available in the Trial Master File (TMF) in accordance with ICH E6. Do documents available in the TMF need to be included in the CSR appendices? 1.59K viewsClinical Research 0 Votes 1 Ans Should my in-patient staff/infusion nurses/rotating staff/residents/pharmacists be included on the Delegation of Authority Log? 1.64K viewsClinical Research 0 Votes 1 Ans Which roles should be on the Delegation of Authority log? 1.70K viewsClinical Research 0 Votes 1 Ans Are there guidelines for budget requests for existing sites looking for renewal? 1.62K viewsClinical Research 0 Votes 1 Ans I work for an institution that is looking into designation, so I was wondering if you have any suggestions for tools to help with this involved process? 1.36K viewsClinical Research 0 Votes 1 Ans Could you provide more details on the note you made regarding DT2 and the extensive review of non-NCI peer-reviewed funding? 1.62K viewsClinical Research 0 Votes 1 Ans How can I include data not mentioned in the ICH E3 text or Appendices since the Guideline pre-dates the ICH M4 Guidelines associated with the CTD and eCTD? Specifically, what are the options for submission of data for topics such as pharmacokinetics, pharmacodynamics, pharmacogenomics (genomic markers), gene therapy, stem cells, biomarkers, devices,quality of life, assay validation, data monitoring/review committees, electrocardiogram, other safety reports, images, pictures/scans, diagnostic tests for individualized therapy, and patient-reported outcomes? 1.50K viewsClinical Research 0 Votes 1 Ans A subject’s death could potentially be captured in two separate data listings: a. The listing referenced in Section 12.3.1.1, Deaths. This section calls for sponsors to include a listing of “all deaths during the study, including the post-treatment follow-up period, and deaths that resulted from a process that began during the study.” b. The listing referenced in Section 12.3.1.2, Other Serious Adverse Events. This section defines other serious adverse events as events “other than death but including the serious adverse events temporally associated with or preceding the deaths.” There is concern that including events with fatal outcomes in 12.3.1.2 may lead to double or mis-counting of deaths. Can this issue be clarified? 1.61K viewsClinical Research 0 Votes 1 Ans Section 12.2.2 of the ICH E3 Guideline states that all adverse events occurring after initiation of study treatments should be displayed in summary tables. The example table in Section 12.2.2 of E3 (Adverse Events: Number Observed and Rate, with Subject Identifications) is really a listing that will rarely be brief enough to place in the body of the study report. Moreover, in addition to severity, relatedness, and subject identifiers (shown in the example table), each adverse event is to include the original investigator’s verbatim term. How is it possible to include all of this information in a summary table? Can this table be modified? 1.48K viewsClinical Research 0 Votes 1 Ans Section 10.2 of the ICH E3 Guideline requests an accounting of important protocol deviations. However, the flowchart in Annex IVa of E3 (Subject Disposition) recommends that data be provided on the number of subjects withdrawn from the study due to “protocol violations.” Neither the term “protocol deviations” nor “protocol violations” has been previously defined by ICH. What is the distinction between a protocol deviation, important protocol deviation, and a protocol violation? Can these terms be clarified? Additionally, does the Guideline allow sponsors’ flexibility in defining what constitutes an important protocol deviation for a trial? 1.61K viewsClinical Research 0 Votes 1 Ans Do you have any examples of Membership, Publications, and Grant tracking systems? 1.25K viewsClinical Research 0 Votes 1 Ans How does a research site maintain compliance with IRB approval requirements if patient recruitment content is included in a blog? 1.51K viewsClinical Research « Previous 1 2 … 9 10 11 12 13 … 18 19 Next » Question and answer is powered by anspress.net
